Kornimate/medical-research-clean huggingface dataset:
aequalis resurfacing head study

Conditions: Localized, Primary Osteoarthritis; Post-traumatic Arthrosis of Other Joints, Shoulder Region; Avascular Necrosis of the Head of Humerus

Summary: aequalis® resurfacing head implant is a range of shoulder arthroplasty device available for the treatment of various shoulder pathologies. it received ce mark in june 2007. the aim of this study is to collect immediate medium and long term data on performance and safety of the implant, retrospectively as well as prospectively, from a consecutive series of patients to assess the patients' outcomes and functional status.

resurfacing head implants allow restoring of the normal joint mechanics and stability of the shoulder with minimal bone resection and low peripheral fracture risk, while preserving humeral bone stock. non cemented head implants also allow for an easy re-intervention if needed. the success of resurfacing implants largely depends on the etiology, with the best results in primary shoulder arthrosis, and the worst in post-traumatic and cuff-tear arthropathy. the aequalis® resurfacing humeral head is designed to restore the humeral head. it shares the same indications as shoulder arthroplasty in general, including the various types of arthritis and conditions resulting in loss of joint cartilage, joint incongruity, pain, and stiffness. resurfacing humeral head implants allow minimal bone resection while preserving humeral bone stock as compared to standard anatomic humeral implants. however, few data are available on mid-term effects of the resurfacing head implant developed by tornier. this post-marketing study is implemented for the aequalis® resurfacing head in shoulder arthroplasty to collect medium and long-term clinical data on performance and safety. it is designed to collect data from consecutive series in european patients for at least 12 months of follow-up and up to 10 years. if possible, the study duration and collection of information will be prolonged. further follow-up can be implemented, by amendments.

Eligibility criteria:
inclusion criteria: * patient has received an aequalis® resurfacing head implant as per the manufacturer's instructions (including the recommended indication): degenerative indication such as primary osteoarthritis, secondary osteoarthritis (post-traumatic post instability), avascular osteonecrosis of the humeral head ; * with a functional rotator cuff ; * has clinical and radiographic follow-up data available ; * is informed about the study and has provided informed consent as applicable. exclusion criteria: * patient with proximal humeral fracture, * previous history of infection, * rotator cuff tear, cuff tear arthropathy, * significant bone loss of the glenoid (more than 25% of the articular surface), * nerve palsy, * revision arthroplasty.
bipolar depression study: bipolar depression assessment study on treatment response

Conditions: Depression, Bipolar

Summary: the primary objective of this study is to assess the efficacy of olanzapine and fluoxetine combined on all the visits as compared with the baseline visit in patients with bipolar disorder, measured by the total score of the montgomery-asberg depression rating scale (madrs).


Eligibility criteria:
inclusion criteria: * meet criteria for bipolar depression, in the opinion of the investigator, according to the diagnostic and statistical manual of mental disorders \[text revision\] (dsm-iv-tr) disease diagnostic criteria. * patients must have experienced, in the opinion of the investigator, at least one previous hypomanic, manic or mixed episode as defined in dsm-iv-tr. * subjects must have an initial score at visit 1 of at least 20 on the madrs. exclusion criteria: * any patient currently meeting dsm-iv-tr criteria rapid-cycling course. * a cgi-severity - mania score of at least 3.
advance: study to evaluate cinacalcet plus low dose vitamin d on vascular calcification in subjects with chronic kidney disease receiving hemodialysis

Conditions: Chronic Kidney Disease; End Stage Renal Disease; Coronary Artery Calcification; Vascular Calcification; Calcification; Cardiovascular Disease; Chronic Renal Failure; Hyperparathyroidism; Kidney Disease; Nephrology; Secondary Hyperparathyroidism

Summary: the purpose of this study is to evaluate whether cinacalcet + low dose vitamin d attenuates the progression of vascular calcification over one year, compared with a treatment regimen that includes flexible vitamin d dosing in the absence of cinacalcet, in subjects with chronic kidney disease receiving hemodialysis


Eligibility criteria:
inclusion criteria: * adults with chronic kidney disease receiving hemodialysis. * lab tests required at screening include parathyroid hormone (pth), calcium, and phosphorus. * a screening coronary artery calcification score of at least 30. exclusion criteria: * subjects on non-calcium or aluminum containing phosphate binders (example: sevelamer hcl, lanthanum) 30 days prior to screening. * subjects on cinacalcet 30 days prior to screening. * current or previous use of some osteoporosis medications. * started or required change in cholesterol lowering medications within 30 days before screening. * abnormal rhythm of the heart. * parathyroidectomy done within 3 months prior to screening. * anticipated parathyroidectomy or kidney transplant. * current intolerance to oral medications, or inability to swallow. * unstable medical condition. * currently enrolled, or fewer than 30 days have passed since subject used another investigational device or drug. * pregnancy or breast feeding.

Keywords: calcification vascular calcification coronary vascular calcification chronic kidney disease end stage renal disease dialysis
a bioavailability study comparing modified-release capsules and immediate release capsules in fed and fasting conditions

Conditions: Healthy

Summary: part 1: the purpose of this study is to determine the pharmacokinetic profile of 4 different extended/modified-release formulations and one immediate release formulation of azd1446. in addition the food effect on azd1446 pharmacokinetics will be investigated. part 2: to asses the safety and tolerability of the selected formulation(s) from part 1 in elderly healthy volunteers.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) between 19 and 30 kg/m2 * clinically normal findings on physical examination exclusion criteria: * history of any clinically significant disease or disorder * history or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs * history or present symptoms or signs of severe allergy/hypersensitivity reactions including severe food allergy, as judged by the investigator

Keywords: phase i relative bioavailability pharmacokinetic study azd1446 healthy volunteers
computertomography-guided wire marking of the liver

Conditions: Secondary Malignant Neoplasm of Liver

Summary: the aim of the study is to evaluate if it is possible to mark with a wire colorectal hepatic metastases after complete response to a neoadjuvant chemotherapy.primary the investigators want to investigate if the wire marking is a possibility to mark respectively to identify these lesions. further the investigators want to evaluate how many patients with complete radiologic have complete histologic response in their specimen respectively in how many specimens in the definitive histology tumor cells are visible.

colorectal cancer is most common in western countries. in 2007 in austria 4462 new colorectal cancers were diagnosed. the most common place of metastasis is the liver. approximately 15% of patients have metastasis at time of diagnosis of primary tumor and further 50% will develop metastases in the further course of the disease.however only 10-25% of patients are candidates for liver resection. new chemotherapeutics, new targeted therapies with monoclonal antibodies and better surgical techniques improved response rates, resection rates and overall survival. owing to improved response rates metastases in the liver partially respectively completely disappeared, so that these lesions are not more visible in apparative diagnostic like ct-scan and mri. the question is now what to do with this patients? in the literature there is no evidence how to manage these patients. conservative management would lead to a reoccurrence of metastases in the liver. on the other side surgical management is difficult, because metastases are preoperatively and intraoperatively not visible and resection is only possible with the removement of greater amounts of healthy tissue. the computer tomography-guided wire marking of the metastases in the liver is a possibility to overcome these problems. all patients with complete radiologic response of metastases in the liver and metastases ≤ 1 cm are included in the study (reciste-criteria). on day of surgical procedure patients will brought to interventional radiologist and based on computer tomography images before neoadjuvant chemotherapy the lesions will be marked computer tomography-guided with a wire(x-reidy breast lesion localization needle, cook medical). the wire is placed percutaneously and under antibiotic prophylaxis. after the marking procedure, the patient is brought into the operating room to resect the metastases in the liver.

Eligibility criteria:
inclusion criteria: * histologic verified cancer of the colon and rectum with metastases into the liver * neoadjuvant chemotherapy with complete radiologic response of metastases in apparative diagnostic respectively metastases with a diameter ≤ 1 cm. * technically resectability * age ≥ 18 years * written informed consent exclusion criteria: * age \< 18 years * technically irresectability * neoadjuvant chemotherapy and response of metastases, however with a diameter \> 1 cm.

Keywords: liver-colorectal metastases-computertomography-guided-wire-chemotherapy-complete response feasibility, safety
retrospective analysis on small bowel perforations

Conditions: Small Bowel Perforations

Summary: a retrospective, monocentric, code-related data analysis of patients with small bowel perforations was performed for the period 2010 to 2019.

analyzed parameters were etiology and timing of perforation, associated morbidity and mortality, type of therapy and its success, and long-term consequences for patients, such as the development of short bowel syndrome.

Eligibility criteria:
inclusion criteria: * small bowel perforation in adults exclusion criteria: * age \< 18 years
measuring skin elasticity in lymphedema patients

Conditions: Diagnoses Disease; Lymphedema

Summary: this protocol will utilize the lymphedema indentometer, or durometer (a novel, noninvasive piece of equipment that measures skin elasticity), to better characterize disease progression in patients with lymphedema. beth israel deaconess medical center patients who undergo treatment of lymphedema will be candidates for this noninvasive test. this device and the data it generates will help understand the incidence of lymphedema at beth israel deaconess medical center compared to national data and the outcomes of surgical treatment of lymphedema.


Eligibility criteria:
inclusion criteria: * patients evaluated by the beth israel deaconess medical center lymphedema team with a diagnosis of lymphedema or determined to be at risk of developing lymphedema in any of their extremities * patients must be over 18 years of age * patients must be willing and capable to provide informed consent * patients must speak english exclusion criteria: * none

Keywords: lymphedema indentometer durometer
fluid in neonatal hyperbilirubinemia

Conditions: Bilirubinemia

Summary: hyperbilirubinemia is a common neonatal problem. bilirubin is potentially toxic to central nervous system and can cause serious permanent complication called kernicterus, in which brain stem nuclei and basal ganglia are damaged,resulting in cerebral palsy.in hyperbiliubinemia,rapid reduction of serum bilirubin level is of utmost importance. two commonly used mode of therapy are phototherapy and exchange transfusion. phototherapy has some side effects such as diarrhea, skin rash, dehydration, overheating, mother-baby bonding disruption.on the other hand, complication of exchange transfusion include infections, emboli,anemia,apnea and hypocalcemia. while iv fluid supplementationis postulated to decrease bilirubin concentration directly through a reduction of haemoconcentration, increasing enteral feed volume is proposed to decrease bilirubin concentration through reduced enterohepatic circulation via an increased gut peristalsis.

bilirubin encephalopathy or kernicterus unconjugated bilirubin is lipid soluble and therefore can cross the blood brain barrier .there it can deposit in areas of the brain, with a predilection for deposition in the basal ganglia, auditory pathways, and oculomotor nucleus. this deposition and accompanying damage result in the classical symptoms associated with kernicterus. hypoxia, acidosis, prematurity, and genetic predispositions all increase the risk for kernicterus.in well term babies risk for kernicterus increases after bilirubin levels cross (20 mg/dl) and it is very high above (30 mg/dl). in preterm babies the threshold for damage from bilirubin could be as low as(20mg/dl). the risk increases with increasing serum levels of unconjugated bilirubin. acute bilirubin encephalopathy presents as lethargy, high pitched cry, poor feeding, abnormal tone, opisthotonus, upgaze palsy and seizures. aggressive treatment at this stage can reduce the damage caused. chronic bilirubin encephalopathy leads to conditions like choreoathetoid cerebral palsy, high frequency hearing loss, dental dysplasias and oculomotor palsies.

Eligibility criteria:
inclusion criteria: 1 -ful term ,body weight (≥2.5kg). 2- total serum bilirubin range(≥18mg/dl to≤25mg/dl). 3-non -haemolytic type of jaundice. 4-ratio of conjugated bilirubin :unconjugated bilirubin is 1:5 exclusion criteria: 1 - body weight ≤2.5kg. 2- evidence of haemolysis. 3- obvious features of dehydration. 4- major congenital malformation . 5- baby received already iv fluid for any reason. 6- septicemia . 7-git functional or organic obstruction .
radiofrequency ablation of low risk papillary thyroid microcarcinoma

Conditions: Papillary Thyroid Microcarcinoma; Thyroid Cancer

Summary: this is a single center prospective clinical trial with regard to efficacy and safety of radiofrequency ablation of papillary thyroid microcarcinoma.

for treatment of papillary thyroid microcarcinoma (ptmc), radiofrequency ablation (rfa) will be performed with the supine position and neck extended under ultrasonogrphic guidance. before rfa, local anesthesia will be performed. rfa system including radiofrequency generator (viva rf system, starmed, goyang-si, korea) and internally cooled electrode (star rf electrode, starmed, goyang-si, korea) will be used. with regard to rfa procedure, moving shot technique and hydrodissection, if indicated, will be used. after rfa, follow-up will be performed using ultrasonography, serum thyroid function test, and questionnaire for quality of life by face-to-face interview at 2 months, 6, 12, 18, 24 months during the first 2 years after rfa, and yearly afterwards.

Eligibility criteria:
inclusion criteria: * who agrees to the consent form * aged from 19 to 60 years old * who has been diagnosed with bethesda category v or vi by fine needle aspiration or needle biopsy * whose thyroid cancer is 1 cm or smaller than 1 cm length * who does not have lymph node or distant metastasis * whose thyroid cancer does not have extrathyroidal extension * in whom it seems technically possible to completely ablate thyroid cancer using rf exclusion criteria: * who cannot routinely followed up according to the study schedule * who has been with bethesda category i, ii, iii, or iv by fine needle aspiration or needle biopsy. * who has hyperthyroidism that requires treatment * who has bleeding tendency * multifocal papillary thyroid microcarcinoma * who is pregnant

Keywords: thyroid diseases radiofrequency ablation
dose-ranging study to evaluate the efficacy, safety, and tolerability of amg 133 in adult subjects with overweight or obesity, with or without type 2 diabetes mellitus

Conditions: Obesity; Overweight; Type 2 Diabetes Mellitus

Summary: the study aims to compare and assess the dose response of 3 selected doses of maridebart cafraglutide compared with placebo, on inducing and maintaining weight loss from baseline at week 52 in participants with overweight or obesity without diabetes mellitus (cohort a) and in participants with overweight or obesity with type 2 diabetes mellitus (cohort b).


Eligibility criteria:
inclusion criteria: * age ≥18 years at the time of signing informed consent. * bmi ≥30 kg/m\^2, or ≥27 kg/m\^2 and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease. * for participants in cohort b only, hba1c ≥ 7% and ≤ 10% (53 to 86 mmol/mol) at screening with an established diagnosis of type 2 diabetes mellitus for ≥ 180 days prior to screening and either treated with diet and exercise alone or on stable (at least 90 days prior to screening) treatment with metformin, a sulfonylurea, or a sodium-glucose cotransporter 2 (sglt2) inhibitor as monotherapy or combination therapy, per approved local label. * history of at least one unsuccessful dietary effort to lose body weight. exclusion criteria: * change in body weight greater than 5 kg within 3 months prior to screening. * obesity induced by other endocrinologic disorders. * history of pancreatitis. * family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (men-2). * history of major depressive disorder within the last 2 years. * any lifetime history of other major psychiatric disorder or suicide attempt.
does adding an additional numbing medication injection in the thigh help with pain control after knee replacement surgery?

Conditions: Knee Osteoarthritis; Knee Rheumatism

Summary: one common anesthetic that is performed for total knee replacement surgery is spinal anesthesia with an adductor canal regional block, which involves injecting numbing medication in the thigh region for pain control after surgery. the aim of this study is to determine whether the addition of another regional block called obturator nerve block, which involves injecting numbing medication in the upper thigh region, will improve pain control after surgery while not sacrificing mobility after surgery.

there is currently no consensus on the optimal strategy that provides the most effective postoperative analgesia while preserving ambulation and limiting side effects such as nausea and vomiting. the clinical team's hypothesis is that the obturator nerve block in addition to adductor canal block can target both the anterior and posterior distribution of nerves to the knee to provide superior analgesia while not limiting ambulation. to test this hypothesis, the clinical team will compare the rate of iv opioid consumption in patients who receive a combination of adductor canal block and obturator nerve block at the surgical site versus patients who receive adductor canal block alone.

Eligibility criteria:
inclusion criteria: * patients scheduled to undergo total knee arthroplasty * planned use of regional anesthesia for procedure * willing and able to provide informed consent exclusion criteria: * patients on immunosuppressive therapy * patients with history of diabetes * patients with lower limb neuropathy * patients with history of chronic opioid use for \> 3 months, including but not limited to, fentanyl, morphine, oxycodone, methadone * patients with known allergy or intolerance to any drug used in the study * patients with history of alcohol or drug abuse * patients with history of intolerance of nonsteroidal anti-inflammatory drugs * patients with hepatic or renal insufficiency * asa score of 4 or greater

Keywords: adductor canal regional block obturator nerve regional block total knee arthroplasty knee replacement surgery knee rheumatoid arthritis
toothbrushing and ventilator-associated pneumonia

Conditions: Ventilator Associated Pneumonia

Summary: the hypothesis is that adding the toothbrushing to the oral care with clorhexidine 0.12% could be reduce the incidence of ventilator-associated pneumonia due to that oral cavity may be an important reservoir of pathogens that could cause pneumonia.


Eligibility criteria:
inclusion criteria: * mechanical ventilation exclusion criteria: * edentulous
360 degree expanded diaphragm exercises in women with stress urinary incontinence

Conditions: Stress Urinary Incontinence; Diaphragmatic Breathing; Pelvic Floor Muscle Exercise; Intra-abdominal Pressure

Summary: this study was planned to examine and compare the effects of standard diaphragm exercises with pelvic floor muscle exercises (pfme) and 360-degree expanded diaphragm exercises with pfme on urinary symptoms, pfm functions and quality of life in women with stress urinary incontinence.


Eligibility criteria:
inclusion criteria: * being a woman, * participating in the research voluntarily, * being between the ages of 18-62, * ability to read and write turkish, * not having any mental problems that would prevent cooperation and understanding, * having a complaint of stress urinary incontinence or stress-predominant mixed urinary incontinence. exclusion criteria: * having received pelvic floor training before, * having a neurological disease, * pelvic organ prolapse stage is stage 2 or higher, * having fecal incontinence, * being pregnant, * lower extremity problems that may affect the pelvic structure (conditions such as lower extremity inequality, total hip arthroplasty) * having an active lower urinary tract infection, * having respiratory system diseases such as chronic obstructive pulmonary disease and asthma, * having undergone hysterectomy surgery.